Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003658 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining pentostatin, cyclophosphamide, and rituximab in treating patients who have chronic lymphocytic leukemia or other B-cell cancers that have been treated previously.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Drug: cyclophosphamide Drug: filgrastim Drug: pentostatin Drug: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I-II Study of Pentostatin With Cyclophosphamide for Previously Treated Patients With Intermediate and High-Risk Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 60 |
Study Start Date: | September 1998 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of cyclophosphamide (CTX).
Cohorts of 3-6 patients receive escalating doses of CTX until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
(Phase I closed to accrual effective 11/27/2001.)
Patients are followed at least every 3 months for 1 year and then periodically thereafter.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I portion of this study. (Phase I closed to accrual effective 11/27/2001.) A total of 14-30 patients will be accrued for the phase II portion of this study within 2.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Intermediate- or high-risk chronic lymphocytic leukemia (CLL) as defined by the three-stage Rai system
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Mark Adam Weiss, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000066751, MSKCC-98083, NCI-G98-1482 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003658 |
Health Authority: | United States: Federal Government |
Waldenstrom macroglobulinemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia refractory chronic lymphocytic leukemia B-cell chronic lymphocytic leukemia stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma contiguous stage II small lymphocytic lymphoma noncontiguous stage II small lymphocytic lymphoma recurrent small lymphocytic lymphoma stage I small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma |
Chronic lymphocytic leukemia Pentostatin Leukemia, Lymphoid Immunoproliferative Disorders Rituximab Leukemia, B-cell, chronic Lymphoma, Follicular Cyclophosphamide Recurrence |
Leukemia Lymphatic Diseases Waldenstrom Macroglobulinemia Leukemia, Lymphocytic, Chronic, B-Cell Waldenstrom macroglobulinemia Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |